• Milk;
• eggs;
• fish;
• crustacean shellfish;
• tree nuts;
• peanuts;
• wheat, and
• soy.

Food Allergen Labeling

Under FALCPA and accompanying FDA regulations, major allergens must be declared in the labeling of all food products (including dietary supplements) sold in the United States. If the major allergens are not appropriately declared, companies face the possibility of detention/refusal, warning letters, and (because allergens invoke serious health risks to consumers) even recalls. Accordingly, it is important for marketers to stay up-to-date with current labeling regulations to avoid costly mistakes.

Interestingly, although the major food allergen list in the United States has some overlap with those food ingredients considered major allergens abroad, there are some distinctions. For example, in the European Union, sesame seeds are already deemed a common allergen, as are celery, mustard and other items not named on the major allergen list in the United States. Thus, as with other labeling components, it is important that importers and marketers of FDA-regulated food products are knowledgeable of FDA food labeling requirements since there are key differences for products sold in the U.S. market.

For more information about food regulations or our services, please visit us at Giannamore-law.com.

FDA Standard of Identity and Dairy Labeling

Under 21 CFR 131.110, the FDA defines “milk” as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cow.” Thus, in order to meet standard of identity requirements for product labeling, a product labeled as “milk” must have animal origin, i.e., be actual dairy. According to dairy industry groups, who support the current standards of identity, labeling almond milk or soy milk as milk is misleading because the product is plant-based and was not derived from a dairy animal. In addition to milk, the regulations pertaining to naming of dairy affects other dairy-based products, like those labeled as cheese and yogurt.

Only time will tell whether the standards of identity for dairy products will be modernized by FDA. If you have any questions about FDA regulations or how you can bring your labels into compliance with FDA regulations, please contact us at contact@sglawfl.com. 

Although the Food Safety Modernization Act (FSMA provides the U.S. Food & Drug Administration (FDA) with the authority to issue mandatory recalls for unsafe food products, most companies issue voluntarily recalls when a mislabeling or adulteration issue arises. One reason that we continue to see voluntary recalls is that the FDA must undertake certain procedures before ordering a mandatory recall.

In order to issue a mandatory recall, the FDA must first determine that the criteria for mandatory recall has been met. Criteria for a mandatory recall may be that the food is adulterated under Section 402 of the Federal Food Drug & Cosmetic Act (FDCA). Adulteration occurs when the food (including dietary supplements) contains poisonous or deleterious substances or a substance that is otherwise unfit for food.  A food may be misbranded under the FDCA when the product labeling does not meet federally mandated requirements. For mandatory recall authority, misbranding under Section 403(w) of the FDCA would be where required major allergens are not displayed in product labeling, thus creating risk to consumers who rely on allergen warnings when making food choices.

Once mandatory recall authority has been established, the FDA must then give the company an opportunity to issue a voluntary recall. If the company still does not undertake a voluntary recall, despite FDA correspondence indicating that the criteria for recall has been met, then FDA can issue a mandatory recall. Because FDA must follow this protocol, it is unlikely that FDA’s exercise of mandatory recall authority will ever become the rule rather than the exception.

If you have any questions about FDA regulation or how you can establish and maintain compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

FDA noted that there are no legally marketed over-the-counter (OTC) drugs that prevent nor cure the flu. However, there are legal OTC products that can reduce fever, relieve muscle aches, congestion, and other symptoms associated with the flu. FDA warns that dietary supplements labeled with flu treatments claims would be regulated as drugs by the Agency as products that are intended to treat, prevent, or cure diseases/conditions are deemed drugs under federal law. Accordingly, marketers of products with these claims should be very careful as they may be in violation of FDA laws and regulations.

In sum, when developing a product, it is important to ensure that all claims made in labeling comply with federal law and regulations enforced by the FDA. If you have any questions about how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com.

FDA Standards of Identity and Dairy Labeling

The term “milk” is defined by the FDA under 21 CFR 131.110 as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cow.” Thus, in order to meet standard of identity requirements, a product labeled as “milk” must have animal origin. According to industry groups backing enforcement of this distinction, labeling almond milk as milk is misleading because almond milk is plant-based and was not derived from a dairy animal. Accordingly, the Bill aims to restrict the ability of beverages made from plant foods from using the term “milk” on their labels. Additionally, enforcement of these regulations pertaining to naming of dairy affects other dairy-based products, like those labeled as cheese and yogurt.

In sum, the Spending Bill directs the FDA to strictly enforce labeling standards of what can be labeled as “milk”. Per the terms of the Bill, FDA has 180 days to release a guidance document detailing how the dairy labeling standards will be implemented and enforced. If you have any questions about FDA regulations or how you can bring your labels into compliance with FDA regulations, please contact us at contact@sglawfl.com. 

Honey is defined as a “thick, sweet, syrupy substance that bees make as food from the nectar of plants or secretions of living parts of plants and store in honeycombs.” If a food contains only honey, then it must be named “honey” and may also include the source of the honey.  Since a honey is a single-ingredient food, it is generally not necessary to include an ingredient statement on the label. If a food contains honey and a sweetener or honey and a flavor ingredient, then it cannot be called “honey”. Rather, the food product would need to bear a standard of identity (again, not “honey”) and bear an ingredient list on the information panel of the label.

FDA Labeling and Regulations for Honey Products

Under federal law, if a food product is labeled “honey” but contains flavor or other ingredients, the FDA would consider this product to be misbranded and/or adulterated. 21 CFR 101.4(a)(1) and 403(i)(2). Additionally, the FDA has an import alert for violative honey products and affected products would be detained until the product is deemed not adulterated or misbranded. Import Alert 36-01.

In sum, whether a product has compliant FDA labeling and is properly marketed as “honey” or a honey-related product with additional ingredients will depend on what ingredients, if any, are added to the honey. Thus, when developing a product to bring to market or importing a product into the United States, it is important to be sure that FDA labeling requirements are considered to ensure that the product is properly regulated.

If you have any questions about the proper FDA labeling of “honey” and honey products or how you can market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@sglawfl.com

But what does the FDA think about “natural” food labeling, and what is legally required to appear on food labels?

While FDA regulations currently do not define “natural” for use in food labeling, the Agency has maintained a longstanding policy concerning the use of “natural” food labeling. FDA’s nonbinding guidance on this subject defines “natural” as “nothing artificial or synthetic (including all color additives regardless of source) has been included in or has been added to, food that would not normally be expected to be in the food.” Although this policy touches on the qualitative aspects of food, this policy does not address production methods and food processing or manufacturing methods. Further, the FDA also does not presently consider in its non-binding guidance whether the term “natural” should describe any nutritional or another health benefit derived from such foods.

Currently, importers and marketers of FDA regulated foods are open to use “natural” claims in labeling so long as the foods meet this minimal standard. However, based on public comments urging FDA to define “natural” for use in food labeling, changes may be on the horizon.

For more information about hiring a FDA regulatory attorney to help you develop FDA-compliant labeling or how you can achieve FDA compliance, please contact us at contact@sglawfl.com.

Getting a FDA Warning Letter for your tobacco business can be confusing. Responding to a FDA Tobacco Warning Letter can be even more confusing and time-consuming for a business. Although people often look to us for a sample response for their FDA Tobacco Warning Letter, unfortunately it is not that simple. While there are some common “Do’s” and “Don’ts”, there is no one-size-fits-all approach in responding to a FDA Tobacco Warning Letter. Accordingly, what we do is offer a tailored plan for responding to and resolving FDA Tobacco Warning Letters.

First, it is important to understand the underlying issues that prompted the Letter. Was it failure to check identification and underage sales or is the problem with labeling, etc.? Depending on the exact issues cited in the Tobacco Warning Letter, there are different measures that should be taken in order to adequately respond. For example, where there are labeling issues, label reviews and updates may be necessary in addition to submitting a response to the FDA to the Tobacco Warning Letter. If the issue is underage sales, there are other corrective measures that can help you bring your business into compliance with FDA requirements.

Once the issues that prompted the Tobacco Warning Letter are fully understood and corrective actions are completed, then a complete response detailing these measures must be addressed to the FDA. In Response to the FDA Tobacco Warning Letter, the Agency will want to see that all regulatory requirements are being addressed in a proactive way and that the business will be able to follow all regulations moving forward. Because these letters are often lengthy and technical in nature, we often provide these services to clients to help them ensure that they address any pending matters that may be of concern to FDA and allow them to get back to business.

For more information about responding to a Tobacco Warning Letter or how we may be able to help, you can contact us at (866)785-0873 or contact@sglawfl.com.

FDA Untitled Letters: Why It Matters?

Many businesses may be well versed when it comes to handling FDA Warning Letters, but when it comes to FDA Untitled Letters recipients of Untitled Letters may not fully understand how to respond. Accordingly, there are a few things to keep in mind once a FDA Untitled Letter is received. First, an Untitled Letter should not go unanswered, as the terms of the Letter require response, and a comprehensive response thereto could potentially save a business from being issued a Warning Letter or other enforcement action.

Differences between FDA Warning Letters and FDA Untitled Letters

1. Warning Letters describe alleged violations with both online marketing materials and print marketing materials, as well as product labels. Conversely, Untitled Letters appear to be focused solely on online marketing materials.

2. Untitled Letters are typically not published on the FDA’s website, unlike FDA Warning Letters, which are routinely published on the FDA website. However, it is important to note that although the Agency does not automatically post FDA Untitled Letters, non-response may trigger publication, reinforcing the importance of a response to FDA Untitled Letters adequately and promptly.

Assistance with FDA Untitled Letters

If you have received an Untitled Letter from the FDA it is vital that you do not disregard the letter. In particular, the receipt of a FDA Untitled Letter may signal an additional chance to resolve the issues cited by the FDA before risking receipt and publication of a FDA Warning Letter. If you are unsure what a FDA Untitled Letter means and what action must be taken, our Firm is available to help you with this process. Whether it be FDA Warning Letters or FDA Untitled Letter we can help you develop and implement necessary, corrective measures before your products or business face consequences. If you are in need of assistance please contact us at contact@sglawfl.com.

The FDA issued this warning to Young Living and its distributors for claiming numerous benefits on the labels of aromatherapy essential oil products with ingredients such as cinnamon, eucalyptus blue, ylang ylang and other essential oils. In addition to their labels, Young Living promoted these essential oils online, including the Company’s websites and social media platforms – with claims that the essential oils treat various conditions.

Here, Young Living was targeted by FDA because its aromatherapy and essential oils were incorrectly labeled and marketed. In particular, the Company failed to follow FDA guidance and regulations applicable to cosmetic products, and instead labeled their products for conditions that caused the products to be deemed drugs by the Agency. Thus, it is important for marketers and sellers of aromatherapy and essential oil products to understand and comply with FDA regulations.

As the aromatherapy and essential oil industry has recently seen a rapid increase in popularity, we expect to see more attention to and FDA enforcement in this area. Compliant labeling of products will help to ensure the successful marketing and sale of the aromatherapy and essential oil products. Our Firm offers the comprehensive label and marketing reviews to help our clients ensure that their products are fully compliant with all applicable FDA regulations. If you would like assistance with your products, please contact us at contact@sglawfl.com or (866)785-0873.